Label: GM COLLIN PURACNE- salicylic acid gel

  • NDC Code(s): 64127-195-01
  • Packager: Laboratoires Dermo-Cosmetik Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 3, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Product / Drug Facts

  • Active ingredient

    Salicylic Acid 2.0%

  • Purpose

    Acne Treatment

  • Uses

    • Helps treat acne pimples.
    • Dries and helps clear up acne pimples.
    • Helps prevent new acne pimples.
  • Warnings

    For external use only.

    Do not useif you have very sensitive skin.

    When using this product

    • Avoid contact with the eyes, lips and mouth; if contact occurs, rinse thoroughly with water.
    • Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one product should be used unless otherwise directed by a doctor.
    • Skin reactions:This product may cause irritation, burning, itching, swelling and blistering of the skin. If any of the above noted symptoms occur, discontinue use.

    Stop use and ask a doctor if

    • The skin reaction becomes severe or spreads beyond the site of application.
    • You develop severe itching, hives, swelling of eyes or mouth, blistering or difficulty breathing.
    • No substantial improvement occurs within 6 to 8 weeks.

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wash hands with a non-medicinal soap.
    • Clean the skin thoroughly with the appropriate G.M. Collin cleanser before applying this product.
    • For New Users: Apply product to a small area once a day for three days to test if you are sensitive to this product.
    • Apply morning and/or evening on the affected areas, or as recommended by your skin care professional.
    • Start with one application daily, then increase if needed.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Other information

    Store at 15-30°C (59-86°F).

  • Inactive ingredients

    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, AQUA/WATER/EAU, BIOSACCHARIDE GUM-1, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CARBOMER, CINNAMOMUM CAMPHORA (CAMPHOR) BARK OIL, CUPRESSUS SEMPERVIRENS OIL,DIMETHICONE, ETHOXYDIGLYCOL, GLYCERIN, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, MADECASSOSIDE, NIACINAMIDE, NORDIHYDROGUAIARETIC ACID, OLEANOLIC ACID, PEG-40 HYDROGENATED CASTOR OIL, PEG-60 ALMOND GLYCERIDES, PEG-8, PELARGONIUM GRAVEOLENS FLOWER OIL, PENTYLENE GLYCOL, PEUMUS BOLDUS LEAF EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, SCLEROTIUM GUM, SODIUM HYALURONATE, TRIETHANOLAMINE, TROPAEOLUM MAJUS FLOWER/LEAF/STEM EXTRACT, XANTHAN GUM.

  • Questions?

    USA: 1 (800) 341-1531 /
    CANADA: 1 (800) 361-1263

  • SPL UNCLASSIFIED SECTION

    www.gmcollin.com
    MADE IN CANADA
    DISTRIBUÉ EXCLUSIVEMENT PAR /
    EXCLUSIVELY DISTRIBUTED BY:
    ® LABORATOIRES DERMO-COSMETIK INC.
    68 STINSON, MONTREAL, QUEBEC,
    CANADA H4N 2E7

  • PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

    G.M. COLLIN

    PURACNE
    GEL

    Acne Treatment

    NDC 64127-195-01
    NPN 80086999

    50 ml - 1.7 fl. oz

    PP label.

  • INGREDIENTS AND APPEARANCE
    GM COLLIN PURACNE 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64127-195
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BIOTIN (UNII: 6SO6U10H04)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O)  
    TROPAEOLUM MAJUS FLOWERING TOP (UNII: RGT30824HY)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    MASOPROCOL (UNII: 7BO8G1BYQU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64127-195-011 in 1 CARTON11/26/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00611/26/2018
    Labeler - Laboratoires Dermo-Cosmetik Inc. (249335480)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!